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Surveillance of Synagis in Korean Pediatric Patients

Respiratory Syncytial Virus Infection Clinical Trial

Official title:
Post-Marketing Surveillance of Synagis in Korean Pediatric Patients Under the "New Drug Re-Examination"

Clinical Trial Summary

Approximately 600 pediatric patients prescribed palivizumab (Synagis) prophylaxis in usual practice according to the approved Korean product label will be registered into this observational study. Baseline data will be obtained at enrollment including demographics, gestational age, birth weight and underlying diseases and complications especially in regard to respiratory disease and cardiovascular disease. At routine visits for Synagis administration, which will occur according to usual medical practice, information on Synagis prophylaxis, concomitant medication, and adverse events will be collected for up to 30 days after the last administration of Synagis.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

  • Respiratory Syncytial Virus Infection
  • Respiratory Syncytial Virus Infections
  • Virus Diseases
Clinical Trial Details
NCT number NCT01537198
Study type Observational
Source AbbVie
Contact
Status Completed
Phase N/A
Start date January 2012
Completion date June 2014
View Details
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